Program Description

In response to our growing capability and the recognized gain from clinical and translational research, the UC Davis Clinical and Translational Science Center (CTSC) uses an integrated resource strategy to decrease barriers to timely research while promoting the protection of human subjects and facilitating regulatory compliance. The demand to accelerate translational science must be paired with a demand for efficient regulatory oversight and processes. Currently, despite their necessity, regulatory programs are often seen by investigators as research impediments. The CTSC maintains human subject protection as a cornerstone of clinical research, while streamlining regulatory processes to decrease the time required for planning, designing, submitting, reviewing, and approving studies.

1. Thoroughly integrate our Regulatory Knowledge and Support function with the overall aim of the CTSC.
2. Expand the established and successful Research Subject Advocate (RSA) Program.
3. Expand the infrastructure of the Clinical/Translational Research Investigator Services Program (CRISP) related to regulatory guidance to provide efficient assistance for CTSC investigators 
4. Provide a regulatory training curriculum and certification program for translational investigators, junior faculty and coordinators to promote GCP.
5. Assure the success of regulatory compliance by:
   1. Providing continuing education in regulatory compliance for investigators through multifaceted collaborations with the Education Training program and through a "free-standing" training curriculum and certification program.
   2. Meticulously monitoring and auditing investigator activities.